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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
US Department of Justice
Federal Trade Commission
US Army

Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087056

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NDA 087056 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Morton Grove, Pliva, Superpharm, Sandoz, Tg United Labs, Naska, Patrin Pharma Inc, Par Pharm, Duramed Pharms Barr, Actavis Mid Atlantic, Impax Labs Inc, Kv Pharm, Zydus Pharms Usa Inc, Pioneer Pharms, Santos Biotech, Watson Labs, Appco Pharma Llc, Apnar Pharma Lp, Ivax Sub Teva Pharms, Halsey, Md Pharm, Lyne, Mylan, Apex Pharms Inc, Vitarine, Ascot, Ingenus Pharms Nj, Pharm Assoc, and Am Therap, and is included in thirty-two NDAs. It is available from twenty-four suppliers. Additional details are available on the CYPROHEPTADINE HYDROCHLORIDE profile page.

The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for NDA: 087056

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 087056

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cyproheptadine hydrochloride
TABLET;ORAL 087056 ANDA Teva Pharmaceuticals USA Inc 0093-2929 0093-2929-01 100 TABLET in 1 BOTTLE (0093-2929-01)
cyproheptadine hydrochloride
TABLET;ORAL 087056 ANDA Teva Pharmaceuticals USA Inc 0093-2929 0093-2929-10 1000 TABLET in 1 BOTTLE (0093-2929-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
US Army
Cantor Fitzgerald

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